Assessing the need for zoning and Enviromental monitoring

Hi all,

I disagree with your statement about ingredients being dry/shelf stable not allowing for pathogenic microorganisms.  Sure, dry ingredients are less likely to support growth, but pathogens can absolutely be present.  According to this report published by the FDA, p64 shows milled flour has the potential for Bacillus cereus, Clostridium botulinum, Pathogenic E. coli, Salmonella spp., and Listeria monocytogenes.  Draft Guidance for Industry Hazard Analysis and Risk-Based Preventive Controls for Human Food: Appendix 1 (January 2024) (fda.gov)

I can also speak from experience in the spice industry: dehydrated vegetables and spices we processed would occasionally test positive for salmonella.  The spice plant had a sister company next store that specialized in dry steam and heat sterilization for dried goods (lots of herbs, teas, sometimes spices were heat treated).  Black pepper is pretty notorious for salmonella as well.  The operating owner for the sterilization side would routinely tell people that pathogens cannot exist if moisture levels are under about 7%, but our own tests on incoming product with those moisture levels would show dry ingredients with unacceptable levels of pathogens present.

As for tests and zoning, company I work for now does mostly cut fruit and veg with a couple plants also USDA inspected for meats.  We do random APC testing on zone 1 for cleaning verification, and Listeria tests for the zones 2, 3, and 4 (salmonella tests added for the meat plants).  The Listeria swabs are taken during routine operation.  For your program, I would recommend taking a closer look at the risks associated with your ingredients and determine if a pathogen is common to all or most and go for that one.

Hi jfrey,

thanks for coming back to me!  I didn't explain well. i'll try to do it.

For combination products I use truffle after a kill step, by drying it to an aw <0.65 (and well above listeria target 70°C for 2 min). I use the sterilized one as an alternative. I combine this ingredient (in small amounts) with other "dry/shelf stable" ingredients (that I buy) such as wheat flour, honey, olive oil, salt for the purpose of flavoring them.

Regarding the particular case of flavored flour, it is not an RTE product (unlike the others) but a ready-to-cook product.

Thank you

...

Now my questions:
- In your opinion, is it necessary to have an environmental monitoring program? If so, what microorganisms would you look for as pathogens (Salmonella) or indicators? I chose to look for indicator microorganisms (e.coli, aerobic plate counts, enterobacteriaceae, for zones 1,2,3,4);
- Would you perform swabbing during production (as for pathogens) or before the start of the shift?

Thaks a lot to all

Lino

 

You have RTE foods exposed to the environment -- yes, environmental monitoring should be occurring.  The organisms you list seem reasonable for mostly dry goods, but if you're performing wet sanitation procedures adding Listeria could be advisable.

Both.  Some should be after sanitation and before production (most non-contact zone samples), and some should be after production has been occurring for 2-4 hours (most contact zone samples).  This tells you both if your environment is harboring these organisms, and if your production activities are contaminating surfaces in such a way as to put product at risk.

I understand what you're defending here, and I would agree the product is low risk from what you describe.  I just wouldn't say the product does not allow for pathogen growth, especially as you combine it with non-RTE ingredients.

As for the need for EM programs, the point is to ensure your environment is not contributing to any pathogen risks.  For example when wet cleaning, the water used there can activate with any product residues on working surfaces, equipment exteriors and floors and lead to contamination risks.  Testing and monitoring of zone 2, 3, 4 areas serves to validate that your cleaning methods are sufficient to control the hazards that could come from the facility itself.  Due to my current company operating high risk environments, we test weekly.  IMO, once you have historical data to support your plant is well under control, you can justify reducing the frequency to monthly or even quarterly.

Now my questions: 
- In your opinion, is it necessary to have an environmental monitoring program?   There arent too many cases where I whould say that a EMP program in not necessary.   In your case I would have one.  

If so, what microorganisms would you look for as pathogens (Salmonella) or indicators? I chose to look for indicator microorganisms (e.coli, aerobic plate counts, enterobacteriaceae, for zones 1,2,3,4);

Salmonella makes sense to me

E. coli makes sense to me. 

enterobacteracea makes sense.   E.coli is an entobacteracea so, doing both might not make sense.    

aerobic plate count makes some sense.  IMO opinion they are usefull after sanitation to validate cleaning.   They are usefull to show how "dirty" equipment becomes over time to justify cleaning schedules, etc.   Not super usefull to determine a pass/fail situation for food safety as the limits are pretty arbitratry.  

- Would you perform swabbing during production (as for pathogens) or before the start of the shift?

Ideally both.   If before production is after a sanitation, it gives you indication that sanitation was effective.    Performing them during production gives you information on what is happening during the production process.     

To be honest, I cant quite figureout what your products and processes are - what risks you control, whats rte and whats not, what a sterilized product is, etc.   However, in general 0.65 will prevent the GROWTH of pathogenic bacteria.   It is not reliably bacterialcidal.  IMO

More importantly and widely misunderstood -  time temperature charts are for specific products.   Especially when you DRY products, all of the standard time temperature charts go out the window.  (and well above listeria target 70°C for 2 min)as you stated.   As you remove moisture, organims like salmonella become more heat resistant.   You most likely need to validate your thermal process.   

Hi kingstudruler1,

thank you (although late) for responding to me!

Regarding the process of drying the sliced truffles I can say that we have done tests and identified the time and temperature required to make the product microbiologically safe.

Instead, I have some doubts about environmental testing. Let me explain. If the target microorganisms in the environmental monitoring plan are spoilage  (also) microorganisms, how and when should they be searched for?  If the target microorganisms in the environmental monitoring plan are the spoilage microorganisms when and where should they be searched for zones 3 and 4? It is clear that if the target microorganisms were pathogens (listeria and salmonella) they should be searched for during work operations. But if pathogenic microorganisms (e.g., listeria) are not considered, should they still be looked for during work operations? Would it make sense to look for total Enterobacteriaceae on the floor or wall during work operations?